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OpenTrials
Completed

NCT Number: NCT00170976

A Year Long Study to Evaluate the Safety of the Combination of Valsartan (320 mg) and Amlodipine (5 mg) in Patients With Hypertension

A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2307.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sites in germany, Multiple Locations, Germany

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • SUCCESSFUL COMPLETION OF VAA489A2307 CORE TRIAL
  • VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg

Exclusion criteria

  • PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2307 CORE

Other protocol-defined exclusion criteria may apply.

Treatment and study plan

valsartan + amlodipine

Drug

Primary outcomes

  1. Adverse events and serious adverse events at each study visit for 6 or 12 months

Secondary outcomes

  1. Change from baseline in diastolic blood pressure from baseline after 6 or 12 months

  2. Change from baseline in systolic blood pressure from baseline after 6 or 12 months

  3. Change from baseline in standing diastolic and systolic blood pressure after 6 or 12 months

  4. Change from baseline in sitting and standing pulse after 6 or 12 months

  5. Hematology and blood chemistry after 6 or 12 months

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 54 Week, Extension to the Double-blind, Multicenter, Multifactorial, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Valsartan (160 mg and 320 mg) and Amlodipine (10 mg) Combined and Alone in Hypertensive Patients

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 15, 2005
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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